NCT02881177

Brief Summary

The purpose of this pilot study is to determine the tolerability, feasibility, and preliminary effectiveness of intranasal oxytocin administration prior to motivational enhancement group therapy sessions on laboratory-based measures of addiction, social connectedness, and stress responsivity in methamphetamine(meth)-using men who have sex with men (MSM). The investigators propose a randomized, double-blind, study of intranasal oxytocin versus placebo 40 IU prior to each of six Motivational Interviewing Group Therapy (MIGT) sessions in 28 mixed HIV sero-status MSM initiating treatment for amphetamine use disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

March 5, 2019

Status Verified

March 1, 2019

Enrollment Period

1.5 years

First QC Date

August 22, 2016

Last Update Submit

March 4, 2019

Conditions

Amphetamine Use Disorders

Keywords

oxytocintolerabilityHIVmen who have sex with men (MSM)addiction

Outcome Measures

Primary Outcomes (1)

  • Side effect profile

    Aim 1: To examine the tolerability of repeated oxytocin dosing in MSM who use meth. Hypothesis 1: There will be no difference in side effect profiles for those receiving oxytocin (40 IU) versus placebo prior to each of six MIGT sessions, and there will be no study-related adverse events.

    6 weeks

Secondary Outcomes (6)

  • Recruitment Rates

    6 weeks

  • urine toxicology

    6 weeks

  • Meth Craving Questionnaire-Brief (MCQ-Br)

    6 weeks

  • attendance rate

    6 weeks

  • Group Questionnaire

    6 weeks

  • +1 more secondary outcomes

Study Arms (2)

Oxytocin

EXPERIMENTAL

Oxytocin 40 International Units (IU) intranasal administration prior to six Motivational Interviewing Group Therapy (MIGT) sessions.

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

Placebo 40 International Units (IU) intranasal administration prior to six Motivational Interviewing Group Therapy (MIGT) sessions.

Drug: Placebo

Interventions

OxytocinDRUG

40 IU

Also known as: Syntocinon
Oxytocin
PlaceboDRUG

40 IU

Also known as: Saline
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • One documented urine toxicology screen positive for meth in the past month
  • Considering initiating treatment for Methamphetamine Use Disorder or initiated treatment within the past month
  • History of sexual contact with men.

You may not qualify if:

  • Urine toxicology screen positive for heroin in the past month
  • Meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for current psychotic disorder, severe neuropsychological disorder, current moderate-severe alcohol use disorder, or suicidal or homicidal ideation with intent within the past 90-days
  • Hemodialysis or inability to produce urine samples
  • Sensitivity to: E 216, E 218, and chlorobutanol hemihydrate (preservatives used in nasal spray)
  • Nasal Obstruction or discharge
  • Using Hormone supplementation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94102, United States

Location

Related Publications (2)

  • Thorson KR, McKernan SM, West TV, Woolley JD, Mendes WB, Stauffer CS. Oxytocin increases physiological linkage during group therapy for methamphetamine use disorder: a randomized clinical trial. Sci Rep. 2021 Oct 25;11(1):21004. doi: 10.1038/s41598-021-99957-8.

    PMID: 34697392DERIVED

  • Stauffer CS, Moschetto JM, McKernan SM, Hsiang E, Borsari B, Woolley JD. Oxytocin-enhanced motivational interviewing group therapy for methamphetamine use disorder in men who have sex with men: study protocol for a randomized controlled trial. Trials. 2019 Feb 21;20(1):145. doi: 10.1186/s13063-019-3225-7.

    PMID: 30791944DERIVED

MeSH Terms

Conditions

HomosexualityBehavior, Addictive

Interventions

OxytocinSodium Chloride

Condition Hierarchy (Ancestors)

SexualitySexual BehaviorBehaviorCompulsive BehaviorImpulsive Behavior

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Chris Stauffer, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 22, 2016

First Posted

August 26, 2016

Study Start

January 1, 2017

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

March 5, 2019

Record last verified: 2019-03

Locations

US(1)